CR 12-X DIGITIZER— 510(k) K131408

Substantially Equivalent

Agfa Healthcare N.V.

FDA 510(k) clearance K131408 for CR 12-X DIGITIZER, Substantially Equivalent on 2013-08-29. Applicant: Agfa Healthcare N.V.. Device class: 2.

Clearance details

Applicant: Agfa Healthcare N.V.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2013-05-15
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.